Classification of Medical Devices

Once the JMDN code is known, the class classification is also known. Knowing the class classification also reveals the pharmaceutical affairs route. Here, let's look at class classification.

The medical device class classification in Japan is based on the class classification rules of GHTF (Global Harmonization Task Force).

• GHTF Class Classification Rules
  • Medical Devices: GHTF SG1 Principles of Medical Devices Classification - November 2012​
  • In Vitro Diagnostic Medical Devices: GHTF SG1 Principles of IVD Medical Devices Classification - February 2008

Under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), medical devices are classified into 4 classes according to the degree of risk to the human body in the event of a malfunction.

• Regarding the classification, approval, certification, and notification of medical devices, Pharmaceuticals and Medical Devices Agency (PMDA)
  • https://www.pmda.go.jp/review-services/drug-reviews/about-reviews/devices/0028.html​​
• Classification and Regulation of Medical Devices
  • Classification clearly described on a single slide: Microsoft Word - 表紙.doc
• Regarding the Revision of Class Classification Rules for Highly Controlled Medical Devices, Controlled Medical Devices, and General Medical Devices (Yaku Shoku Hatsu 0 5 1 0 Dai 8 Go)
  • Notification showing the concept of class classification in Japan based on the above GHTF class classification rules: 000242914.pdf
• Guidelines on the Medical Device Applicability of Programs
  • Section "6: Concept of the degree of risk affecting human life and health" in the material supplements the above notification regarding the concept of class classification for program medical devices. 000240233.pdf

Class I: General Medical Devices

• Definition:
  • Devices considered to pose an extremely low risk to the human body even if a malfunction occurs.
• Regulation:
  • "Notification" of marketing approval to the Pharmaceuticals and Medical Devices Agency (PMDA) is required. Approval or certification is not required.
• Specific Examples:
  • Surgical Instruments: Scalpels, tweezers, forceps, scissors
  • Diagnostic Tools: Stethoscopes, tongue depressors
  • Sanitary Materials: Adhesive bandages, gauze
  • Others: X-ray film, most dental laboratory equipment

Class II: Controlled Medical Devices

• Definition:
  • Devices considered to pose a relatively low risk to the human body if a malfunction occurs.
• Regulation:
  • "Certification" by a third-party certification body registered based on law is required (some items require approval).
• Specific Examples:
  • Diagnostic Imaging Systems: MRI devices, ultrasonic diagnostic devices, CT scanners
  • Biological Information Monitors: Electronic thermometers, electronic blood pressure monitors, electrocardiographs
  • Treatment Instruments: Catheters for digestive organs, injection needles
  • Others: Home-use massage devices, hearing aids, electronic endoscopes

Class III: Highly Controlled Medical Devices

• Definition:
  • Devices considered to pose a relatively high risk to the human body, requiring appropriate management because a malfunction could have a serious impact on life or health.
• Regulation:
  • Marketing "Approval" from the Minister of Health, Labour and Welfare is required. Submission of clinical trial results may be required for the approval application.
• Specific Examples:
  • Life Support/Substitute Devices: Ventilators, dialyzers, infusion pumps
  • Implant Products: Artificial bone, artificial joints, dental implants
  • Treatment Instruments: Vascular catheters, laser surgical devices
  • Others: Contact lenses that contact blood or tissue for a long period

Class IV: Highly Controlled Medical Devices

• Definition:
  • Devices considered to pose an extremely high risk to the patient, requiring particularly cautious management because side effects or functional impairment could directly lead to danger to life, and which are highly invasive to the human body.
• Regulation:
  • Similar to Class III, marketing "Approval" from the Minister of Health, Labour and Welfare is required. The approval review is conducted with the utmost rigor.
• Specific Examples:
  • Cardiac/Vascular Implants: Pacemakers, implantable cardioverter-defibrillators, artificial heart valves, coronary stents
  • Cerebral/Nervous System Devices: Deep brain stimulators
  • Others: Cardiopulmonary bypass machines, products using biological raw materials

Class classification can also be estimated from information on similar products.
In the case of new medical devices for which an existing JMDN code does not exist, there may be no similar product, and thus the class classification is unknown. In this case, referring to the aforementioned class classification rules provides a general estimate. Ultimately, the PMDA decides it during the review process.

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